Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of them that watched the vote on the Parliament’s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the text of the proposal? What was that?
To clarify what happened: today the Parliament voted on the request to treat the MDR proposal in the accelerated procedure, which was literally what it said in the Parliament’s agenda, so no surprise there if you know how this works. By the way, it’s an IVDR proposal too and not just an MDR party, as the IVDR sell-off period is proposed to be removed.
While it had been pre-discussed with the Commission that this would be put on the agenda and preferably adopted rapidly without issues, drama or amendments in the accelerated legislative procedure, rule 163 of the Parliament’s procedures still requires a vote on this. And that happened today.
The vote was unanimous and now the vote on the substance of the proposal is scheduled for Thursday 16 February. Amendments can (theoretically) still be proposed by the Parliament on Wednesday, but also on this point solid pre-discussion between the Commission and the ENVI committee will likely lead to a no amendment situation.
If you want to check out the proposal for inconsistencies between languages or in your own language (or in another of the many interesting ones we have in the EU), see here as it has been translated in all language versions (a requirement for adoption).
So please bear with the Parliament for just another two days until the vote on the proposal, and then some more days as the proposal will trickle through the publication process to the Official Journal.
And, as the name of the journal suggests, it’s not official until published in the Official Journal – and since the proposal indicates that the normal 20 days delay period after publication is foregone for this proposal – it will enter into force on the date of publication in the Official Journal and not before. There is no official timeline for that. For the last accelerated amendment to the MDR it took about a week between vote in the Parliament and publication in the Official Journal – Parliament vote was on 17 April 2020, and the amendment was published in the OJ on 24 April 2020 (one week later). So let’s hope they can be just as quick this time. I know that it will make a difference for certificates expiring already, so no time to waste!
In the mean time, the proposal leaves many questions unanswered, so if you have any: don’t hesitate to contact me because answering those questions is what I do best. And boy, did I answer a few about this proposal already. I can safely say that now (actually some time before already) is a good time to make some scenarios about how the proposed amendment will affect your devices business if you haven’t yet done so. Scenario anyone?
medicaldeviceslegal 
Thanks for the information.
My scenario: my company work to get the CE market under the MDR for the first time. So this amendement will impacts to my company?.
No, it will not. It targets legacy devices, i.e. devices with a certifcate issued before 26 May 2021 or with a current article 59 or 97 MDR exemption/derogation from CE marking.
Thanks so much for your answer!.
Dear Erik,
how does the proposal for removing the “sell-off period” impact independent IVD MDSW put into service before IVDR DoA (DoC acc. to IVDD and reclassified to class C acc. to IVDR), which is offered by means of information society service according to IVDR Art. 6 (i.e. Software as a Service) providing diagnostic services for patient management at health institutions?
Each new license sold is a new device that can put into service. For your device that would mean that I would sell *a lot* of license keys to my Union distributor/reseller because he can still make the devices available to end users after the end of the transition period for class C devices.
Thanks´ Erik, that makes sense and is a great opportunity while we´re also preparing for the IVDR-certification.
Appreciate the update
Very welcome!
My questions are specific regarding devices under IVDR.
Article 2(1) of the proposal – 𝗱𝗲𝗹𝗲𝘁𝗶𝗼𝗻 of the ‘𝘀𝗲𝗹𝗹-𝗼𝗳𝗳’ deadlines in the #IVDR This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in “Article 110(4) #IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction”….. so according to this, if my devices have been placed on the market before the end of the transition period for class B devices (May 2027) (most of my devices fall under this category, and are under IVDD), does that mean I can still make available my devices for unlimited time? Does this mean we don´t need to work under IVDR and can still be working with devices under IVDD? Could you please explain what exactly “deletion of the sell-off deadlines” mean for IVDR? KIND REGARDS AND THANKSF FOR THIS BLOG!
All legacy devices placed on the market before the end of the transitional period that applies to them under the IVDR can indeed be made available forever – this concerns potentially all the stock you can produce and sell into the Union up to the end of the transitional period. All devices that you want to place on the market after the end of the transitional period will need IVDR CE marking, so you will need to work with the IVDR.
Thank you Erik! 🙂
Another scenario: my certificate has already expired, and I am still in the process of getting my MDR CE mark. When I’m reading the proposal, it seems I can now just place again devices on the market, and that’s it (once published of course). Am I missing something?
Thank you for this blog!
If you fit the conditions for reliving of the certificate under article 120 (2) (a) as amended then your certificate will relive on the date of entry into force of the amendment. If you are also in the MDR procedure already then you don’t need to worry about the 2024 deadlines in article 120 (3d) as amended.
Thank you! This sounds so weird to me, and raises so many questions: what about the surveillance by the notified body? Do I need a new contract? Will they have time for that?
It really seems this case was not considered by the regulator